Bioequiavailability of Folinate for Injection in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To study the bioequiavailability of sodium/calcium folinate for injections in healthy volunteers.METHODS:By a randomized crossover design,trichloracetic acid was used to precipitate the protein in serum sample.Serum concentration of folinate was determined by RP-HPLC.The pharmacokinetic parameters and relative bioavailability of sodium folinate for injection vs.calcium folinate for injection were computed and analyzed statistically.RESULTS:The pharmacokinetic parameters of single dose of sodium folinate for injection(trial formulation)vs.calcium folinate for injection(reference formulation)were as followstmax(0.292?0.096)h vs.(0.25?0)h;Cmax(31.973?4.337)?g?mL-1 vs.(33.332?3.312)?g?mL-1;AUC0～24(139.670?13.859)?g?h?mL-1 vs.(144.401?13.574)?g?h?mL-1;AUC0～∞(154.246?16.481)?g?h?mL-1 vs.(161.306?17.871)?g?h?mL-1;MRT0～24(6.795?0.73)h vs.(6.963?0.713)h;t1/2(7.183?1.469)vs.(7.316?2.045).The mean relative bioavailability of the sodium folinate for injection was(98.2?37.1)%.CONCLUSION:The two formulations are proved to be bioequivalent.